title: Outsourcing ethical obligations: should the revised common rule address the responsibilities of investigators and sponsors?
abstract: The Common Rule creates a division of moral labor in research. It implies that investigators and sponsors can outsource their ethical obligations to IRBs and participants, thereby fostering a culture of compliance, rather than one of responsibility. The proposed revisions to the Common Rule are likely to exacerbate this problem. To harness the expressive power of the law, I propose the Common Rule be revised to include the ethical responsibilities of investigators and sponsors.
authors.affiliation: Clinical Center Department of Bioethics.
authors.forename: Seema K
authors.initials: SK
authors.lastname: Shah
mesh_terms: D028744:Ethics Committees, Research; D032984:Ethics, Research; D006805:Human Experimentation / Q000941:ethics* / Q000331:legislation & jurisprudence; D006801:Humans; D012108:Research Personnel / Q000941:ethics*; D035842:Research Subjects / Q000331:legislation & jurisprudence; D014481:United States